Accro, Fosun Pharma Secure China Nod for Phase II/III Trial of AC-201 in Vitiligo

10 September 2026 | Thursday | News


NMPA clears adaptive seamless trial of the novel oral TYK2/JAK1 inhibitor AC-201 for non-segmental vitiligo, advancing its clinical development in mainland China.

Accro Bioscience (Suzhou) Limited ("Accro") today announced that Shanghai Fosun Pharmaceutical Industrial Development Company Limited ("Fosun Pharma Industrial"), a subsidiary of its partner Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"), has received approval from China's National Medical Products Administration (NMPA) to conduct a Phase II/III adaptive seamless design clinical trial of AC-201 tablets (Fosun development code: FXS5626) for the treatment of non-segmental vitiligo. Fosun Pharma Industrial plans to initiate the relevant clinical trial for this indication in mainland China once the necessary conditions are met.

AC-201 is a novel, highly selective and potent oral small-molecule inhibitor of TYK2/JAK1 that binds to the pseudo kinase domain (JH2) of TYK2/JAK1, with minimal effect on the JAK2/JAK2 signaling pathway. It is currently being developed to treat immune mediated inflammatory diseases.

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